We provide accurate translations for all the documents involved with clinical trials, including:
- Study protocols
- Informed Consent Forms (ICFs)
- Patient Reported Outcome (PRO) forms
- Instructions for investigators
- Instructions for patients
- Patient records
Thanks to uniform translations your trial will be conducted in the same way in every country, enabling you to compile results from different language areas without difficulty.
For certain types of trial documents a back translation is required. Of course, we do those also, if requested following the ISPOR Guideline, which includes a double forward translation, reconciliation of the two versions, and then a back translation.
More than meaning
A well-translated text isn’t just about getting the meaning of the words across. Clear and unambiguous patient information sheets will help you in the recruitment of trial participants and make sure the data they provide is correct. A clearly-worded study protocol is more likely to be accepted by authorities and medical ethics committees. We can of course test these documents for comprehensibility and readability.
We are familiar with the new Clinical Trial Regulation (EU 536/2014).